Center for Scientific Review; Notice of Closed Meetings, 9906 [2010-4487]
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Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
Cell Substrates and Other Biological
Starting Materials Used in the
Production of Viral Vaccines for the
Prevention and Treatment of Infectious
Diseases,’’ dated September 2006. FDA
received numerous comments on the
draft guidance and those comments
were considered as the guidance was
finalized. In addition, editorial changes
were made to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
September 2006, and replaces
information specific to viral vaccines for
the prevention and treatment of
infectious diseases contained in the
1993 document entitled ‘‘Points to
Consider in the Characterization of Cell
Lines Used to Produce Biologicals.’’ The
guidance is also intended to supplement
recommendations on the production of
viral vaccines for the prevention and
treatment of infectious diseases,
provided in the International
Conference on Harmonisation (ICH)
guidance documents entitled ‘‘Q5A Viral
Safety Evaluation of Biotechnology
Products Derived from Cell Lines of
Human or Animal Origin’’dated
September 1998 (63 FR 51074;
September 24, 1998) and ‘‘Q5D
Derivation and Characterisation of Cell
Substrates Used for Production of
Biotechnological/Biological Products’’
(63 FR 50244; September 21, 1998).
For the production of biological
products not covered under this
guidance, we recommend that you refer
to the ‘‘Points to Consider in the
Characterization of Cell Lines Used to
Produce Biologicals,’’ dated 1993.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act
The guidance refers to previously
approved collections of information
found in FDA Regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). Most of the collections of
information to which the guidance
refers are covered by 21 CFR part 601
(BLAs (biologics license application))
and part 312 (INDs (investigational new
drugs)), and were approved under OMB
Control No. 0910–0338 and 0910–0014,
respectively. For the remaining
VerDate Nov<24>2008
16:39 Mar 03, 2010
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referenced collections of information,
those in 21 CFR 640.3 and 640.63 have
been approved under OMB Control
Number 0910–0116; those in 21 CFR
part 211, including § 211.160(b), have
been approved under OMB Control
Number 0910–0139; and those in 21
CFR part 58 have been approved under
OMB Control No. 0910–0119.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) elecronic
or written comments regarding the
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
Dated: March 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–4553 Filed 3–3–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
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Name of Committee: Center for Scientific
Review Special Emphasis Panel, Program
Project: Computational Resource Review.
Date: March 24–26, 2010.
Time: 6:30 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Estancia La Jolla Hotel & Spa, 9700
N. Torrey Pines Road, La Jolla, CA 92037.
Contact Person: Raymond Jacobson, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5858,
MSC 7849, Bethesda, MD 20892. 301–996–
7702. jacobsonrh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Program
Project: Opiate Drug Abuse and CNS
Vulnerability to HIV.
Date: March 25–26, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive,Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Robert Freund, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3200,
MSC 7848, Bethesda, MD 20892. 301–435–
1050. freundr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Fellowships: AIDS Predoctoral and
Postdoctoral.
Date: March 30–31, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Hilary D. Sigmon, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892. (301) 594–
6377. sigmonh@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 25, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4487 Filed 3–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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[Federal Register Volume 75, Number 42 (Thursday, March 4, 2010)]
[Notices]
[Page 9906]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Program Project: Computational Resource Review.
Date: March 24-26, 2010.
Time: 6:30 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: Estancia La Jolla Hotel & Spa, 9700 N. Torrey Pines Road,
La Jolla, CA 92037.
Contact Person: Raymond Jacobson, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5858, MSC 7849, Bethesda, MD
20892. 301-996-7702. jacobsonrh@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Program Project: Opiate Drug Abuse and CNS Vulnerability to
HIV.
Date: March 25-26, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge
Drive,Bethesda, MD 20892. (Virtual Meeting.)
Contact Person: Robert Freund, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3200, MSC 7848, Bethesda, MD 20892. 301-435-
1050. freundr@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Fellowships: AIDS Predoctoral and Postdoctoral.
Date: March 30-31, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892. (Virtual Meeting.)
Contact Person: Hilary D. Sigmon, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD
20892. (301) 594-6377. sigmonh@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: February 25, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-4487 Filed 3-3-10; 8:45 am]
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